Batch Release

Any facility that will conduct European batch release testing must be identified in the Marketing Authorization Application (MAA) for the product 

FDAS is a skilled contract testing laboratory that can handle all of your Quality Control testing necessary to release a medicinal batch for sale

Within the European Union (EU), there is a regulatory requirement that each batch of a marketed product is tested by an EU accredited GMP testing laboratory against the approved product release specification of the Marketing Authorisation (MA) 

FDAS works with customers to minimise the time from manufacture to availability by the patient.

  • Commercial product batch release of marketed products
  • IMP batch release testing and re-test
  • QP services
  • QP sample inspection
  • Retained sample storage

If you would like to get in touch with us then please call.

Contact us

  • Biocity Nottingham
    Pennyfoot Street
    NG1 1GF